Endologix, Inc

  • Sr. Manufacturing Engineer

    Job ID
    2018-1875
    Location
    US-CA-Santa Rosa
    Category
    Operations
  • Overview

    Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

    Responsibilities

    • Design and develop manufacturing processes for new products and/or changes to existing products
    • Design and develop fixtures and tooling for manufacturing process
    • Develop and execute process validation protocols (IQ/OQ/PQ)
    • Analyze process data and make decisions/recommendations relating to process capability and DFM
    • Perform Installation Qualification (IQ) equipment protocols and reports
    • Investigate benefits and features of capital equipment and generate capital appropriation justifications
    • Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions
    • Provide engineering support to production department in troubleshooting and resolving technical problems.
    • Contact and address component and/or raw material issues with suppliers
    • Support manufacturing and quality with addressing NCMR issues
    • Plan, schedule, and complete projects in a manner consistent with business objectives
    • Contribute to the intellectual property position of the company via invention and patent applications
    • Maintain accurate documentation of concepts, designs, and processes.
    • Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
    • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
    • Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved
    • Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance
    • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
    • Ensure that all regulatory and internal policies are followed
    • Assist engineering manager in development of engineers providing assistance with coaching and mentoring
    • Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
    • Perform other duties as assigned by supervisor

    Qualifications

    • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
    • Has the ability to use moderate to advanced  statistic techniques when analyzing data and make rational and logical decision base the that analysis
    • Applicable knowledge of Minitab, JMP, or other statistic tools
    • Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)
    • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.   
    • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

    Education:

    • Requires a Bachelop of Science degree in Engineering or related technical degree (i.e. physics or mathematics)

    Experience:

    • Five years with a Bachelor's degree, Three years with a Master's degree of directly relevant


     

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